DE10047993A1 - Bearer of markings or standard for generating image data is ready-made navigation rail with exchangeable marking substance containers fixed in latching knobs to exterior of bearer - Google Patents

Abstract

The device has a bearer for attachment to the jaw of the subject and a contrast marking substance held in at least three containers. The bearer is in the form of a ready-made navigation rail with exchangeable containers for marking substance fixed in latching knobs to the exterior of the bearer, which can be repeatedly accurately applied to the patient. Independent claims are also included for the following: a medical process.

Description

The invention relates to assembled navigation rails for creating image data for a database using magnetic resonance imaging, computed tomography or other imaging Procedure and for recording the position of a subject and Coordinate assignment for surgical interventions with the support of a Navigation system.

In addition to the clinical examination with inspection, manual scanning and functional diagnostics, the surgeon has access to medical imaging methods such as X-rays and sonography. As a rule, these are two-dimensional images. The combination of different two-dimensional image sets from different radiation directions enables the doctor to take into account the spatial reconstruction of the object, taking anatomical knowledge into account. This is e.g. B. used for the reconstruction of damaged parts of the body. Since the early 1990s (Schubert, R., M. Bomans, KH Höhne, A. Pommert, M. Riemer, T. Schiemann, U. Tiede, W. Lierse. A new method for representing the human anatomy. Comput. Med Imaging Graph 17 ( 1993 ), p 243-249; Carls, FR, B. Schuknecht, HF Sailer. Value of three-dimensional computed tomography in craniomaxillofacial surgery. J. Craniofac. Surg. 5 ( 1994 ), 282-288 ; Kikinis, R., PL Gleason, TM Moriarty, MR Moore, E. Alexander, P. Stieg, M. Matsumae, WE Lorensen, HE Cline, PM Blach, FA Jolesz.Computer-assisted interactive three-dimensional planning for neurosurgical procedures . Neurosurgery 38 ( 1996 ), 640-649), methods are known which visualize two-dimensional image data using 3D models (Klimek, L., HM Klein, T. Mösges, B. Schmelzer, W. Schneider, ED Voy. Methods for simulating surgical interventions in head and neck surgery: ENT 40 ( 1992 ), 446-452; Lill, W., P. Solar, C. Ulm, F. Watzek, R. Blahout, M. Mateijka. Reproducibility of three- dimension al CT-assisted model production in the maxillofacial area. Br. J. Oral Maxillofacial Surg. 21 ( 1992 ), 501-516) or on the computer screen (Bonnier, L., K. Ayadi, A. Vasdev, G. Crouzet, B. Raphael. Three-dimensional reconstruction in routine computerizd tomography of the skull and spine. J. Neuroradiol. 18 ( 1991 ), 250-266; Robb, RA and DP Hanson. A software system for interactive and quantitative visualization of multidimensional biomedical images. Austral. Phys. Eng. Sci. Med. 14 ( 1991 ), 9-30; Schubert, R., WJ Höltje, U. Tiede, KH Höhne. 3D representations for maxillofacial surgery. Radiologie 31 ( 1991 ), 467-473; Cline, HE, WE Lorensen, SP Souza, FA Jolesz, R. Kinikis, G. Gerig, TE Kennedey. 3D surface rendered MR images of the brain and its vasculature. J. Comput. Assist. Tomogr. 15 ( 1991 ), 344-351; Vogl, TJ, J. Assal, C. Bergman, G. Greves, T.

Wustrow, C. Hamburger, C. McMahon, J. Lissner. Three-dimensional MR reconstruction images of skull base tumors. J. Magn. Reson. Imaging 3: 367-374 ( 1993 ); Pommert, A., M. Riemer, T. Schiemann, R. Schubert, U. Tiede, KH Höhne. Three-dimensional imaging in medicine: Methods and applications. In: Taylor, RH, Lavalée, S., Burdea, BC, and Mösges, R. (eds.): Computer-integrated Surgery, MIT Press, Cambride, MA, London, ( 1996 ), p. 663- 671). This has made three-dimensional planning and simulation of operations on the computer and model possible. Lambrecht, JT, H. Schiel, A. Jacob, T. Kreusch provide an overview of interactive planning. CAR-CAD-CAM-CAS: 3D perspectives. In: Lemke, H., Inamura, K., Jaffe, CC, Vannier, MW (eds.): Computer Assisted Radiology: Proceedings of the International Symposium on Computer and Communication Systems for Image Guided Diagnosis and Therapy. CAR '95 Berlin June 21-24 . Springer Verlag Berlin, Heidelberg, New York, Tokyo ( 1995 ), p 1364-1368) and Patel, V., M. Vannier, J. Marsh, L. Lo. Evaluatin of digital surgical simulation. In: Lemke, H., Inamura, K., Jaffe, CC, Vannier, MW (eds.): Computer Assisted Radiology Proceedings of the International Symposium on Computer and Communication Systems for Image Guided Diagnosis and Therapy. CAR '95 Berlin June 21-24 . Springer Verlag Berlin, Heidelberg, New York, Tokyo ( 1995 ), p 1364-1368).

The combination of different radiological methods such as e.g. B. computer tomography (CT) or magnetic resonance imaging (MRI) by overlaying the image sets the generation of a multidimensional computer model. This method, known as "matching" or "fusion", offers the operation planner the possibility of different qualities of the examined body region, e.g. B. soft tissue (skin, muscle, fatty tissue or tumorous tissue) or in contrast hard tissue (bone, cartilage, penetrated foreign bodies) on the screen and pinpoint it. In addition to CT and MRI data, image sets from positron emission tomography (PET), single photon emission tomography (SPECT) or digital subtraction angiography (DAS) and other imaging methods can also be integrated (Jannin, P., Ch. Grova , D. Schwartz, Ch. Barillot, B. Gibaud. Fusion of multimodal functional neuro-imaging (MEG, fMRI, SPECT): Definition of different matching paradigms. In: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.): CARS '99: Computer Assisted Radiology and Surgery. Proceedings of the 13 ^th international Congress and Exhibition, Paris, June 23-26 , 1999. Elsevier, Amsterdam, New York, Tokyo, ( 1999 ), p 238-243). Most digital imaging methods can now be "matched" using new conversion algorithms (Eldeib, A., AA, Farag, T. Moriarty. A fast genetic search algorithm for accurate multi-modal volume registration by maximizing mutual information. In: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.): CARS '99.. computer Assisted Radiology and Surgery Proceedings of the 13 ^th international Congress and Exhibition, Paris, June 23-26, 1999 Elsevier , Amsterdam, New York, Tokyo, ( 1999 ), p 244-248; Shahidi, R., B. Wang, M. Epitaux, J. Adler, G. Steinberg. Intraoperative video and volumetric image fusion. In: Lemke, H ., Inamura, K., Vannier, MW, Farmann, AG (eds.): CARS '99: Computer Assisted Radiology and Surgery. Proceedings of the 13 ^th international Congress and Exhibition, Paris, June 23-26 , 1999. Elsevier, Amsterdam, New York, Tokyo, ( 1999 ), p 625-630). An important prerequisite for the "matching" process is the exact overlay of the different data records. With layer thicknesses of a few millimeters in computer tomograms, even the smallest patient movements impair the accuracy and also the possibility of fusing the images obtained. Since the patient has to get from one examination room (e.g. CT) to the next (e.g. MR, SPECT or the like), options were sought to guarantee a reproducible position of the patient in the examination device.

Neurosurgery played a pioneering role in this area. As early as 1908 , Clarke introduced a stereotaxic frame that was firmly screwed to the patient's head, which allowed a stable, reproducible position of the head. The frame is also shown in the imaging, so that a metric connection of anatomical and pathological structures to the frame on the images is possible. With the help of these "stereotactic frames", which are still used today as surgical aids (Melikian, AG, MI Kazamovskaya, AV Stock, AV Colanov, SM Ignatov, SA Lobanov. CT-guided computer-assisted stereotactic resection of brain tumors. Acta Neurochir Suppl. 131 ( 1994 ), 274-281; Thomas, DG, and ND Kitchen. Minimally invasive surgery. Brit. Med. J. 308 ( 1994 ), 126-128; Ebling, U., and MG Hasdemir. Stereotactic guided microsurgery of cerebal lesions. Minim. Invasive Neurosurg. 38 ( 1995 ), 10-15), a reference basis was created which kept the position of the skull in relation to the frame and the markings there (Levin, DN, CA Pelizzari, GT Chen , CT Chen, MD Cooper. Retrospective geometric correlation of MR, CT and PET images. Radiology 169 ( 1988 ), 817-823; Pelizzari, CA, GT Chen, DR Spelbring, RR Weichelbaum, CT Chen. Accurate three-dimensional registration of CT, PET, and / or MR images of the brain. J. Comput. Assist. Tomogr. 13 ( 1989 ), 20-26). Image fusion can thus be made possible via the stereotaxy frame.

The computer-assisted three-dimensional visualization of the operation planning and the intraoperative navigation through computer-controlled or manual systems are particularly useful for complex fractures of the face and brain skull, tumorous changes or dysmorphisms in the head and neck area. Such navigation systems, which have been available to the surgeon since the mid-1980s, make it possible to display the position of a surgical instrument in the surgical field (Roberts, DW, JW Strohbein, JF Hatch, W. Murray, H. Kettenberg. A frameless strereotactic integration of computerized tomographic imaging and the operating microscope. J. Neurosurg. 65 ( 1986 ), 545-549; Watanabe, ET Watanabe, S. Manaka, Y. Mayanagi, K. Tanakura. Three-dimensional digitizer (neuronavigator): new equipment of computedtomography-guided stereotactic surgery Surg. Neurol. 27 ( 1987 ), 543-547; Kosugi, Y., E. Watanabe, J. Goto, T. Watanabe, S. Yoshimoto, K. Takakura, J. Ikebe. An aticulated neurosurgical navigation system using MRI and CT images. IEEE Trans. Biomed. Eng. 35 ( 1988 ), 147-152; Adams, L., A. Knepper, W. Krybus, D. Meyer-Ebrecht, G. Pfeifer, R. Ruger, M. Witte Orientation aid for head and neck surgeons. Innov. Tech. Biol. Med. 13 ( 1992 ), 410-424; Mösges, R. Computer-aided Chi rurgy (CAS) of the skull base region. Complementary, revolution or science fiction? Eur. Arch. Otorhinolaryngology 250 ( 1993 ), 373-383; Reinhart, HF, GA Horstmann, O. Gratzl. Sonic stereometry in microsurgical procedures for deep-eated brain tumors and vascular malformations. Neurosurgery. 32 ( 1993 ), 51-57), both preoperative simulation and intraoperative navigation of the instruments being made possible, so that small and deep-seated lesions, e.g. B. can be targeted in the brain. Another example are surgical interventions in the field of ear, nose and throat medicine, in which, for example, a navigation system can be used to safely differentiate between the borders of the sinuses and the brain. This is a further step in patient education by visualizing the planned operation, but also in quality assurance of the result of the operation by determining the position of instruments, tissues or implants at any time during the operation.

Navigation systems that work with different tracking methods are known. For example, the patent specifications DE 199 09 816 and US 6,071,288, hereby in all of them are included as a reference. In the known systems a preoperative image of the anatomy or brain of the Test subjects or patients made. Via a tracking system with an optical sensor there is then the possibility of using the preoperatively acquired image data display sections or views of the head on a monitor. Requirement one exact positioning during the operation are referencing features. At the preoperative scanning using computer and / or magnetic resonance imaging are used for  Coordinate assignment either anatomical features or so-called fiducial markers used, fixed on the patient's skull surface, immobile in its position Markers. These referencing features are used to localize the Recordings taking into account the respective spatial orientation.

Previously known fiducials, i.e. H. Marking devices for creating image data by means of magnetic resonance and / or computed tomography or for the position detection of the position of a Subjects and coordinator assignment during surgical interventions with the support of a Navigation systems have a relatively large spatial extent and lead to unpleasant disabilities of the patient, in particular due to the time Distance between the nuclear spin and computed tomography images on the one hand and the later surgical intervention on the other hand. For the assignment of coordinates, the Fiducials remain on the patient's head, which is understandably uncomfortable.

Known neuro navigation systems operate in conjunction with the head of the Patient-encompassing frame that firmly encloses the head and for the determination of the three-dimensional position of a point is necessary. In US 5,230,623, hereby in included in its entirety as a reference, such a framework is described, which is not is attached directly to the head, but with a bite plate for locking and Centering of the head is used. A similar design is described in US 5,549,616, hereby incorporated in its entirety as a reference, described where a indirect, d. H. mouthplate made in the laboratory, which is characterized by the impression of the upper jaw is molded for the accurate and reproducible positioning of a patient's head in a holder for stereotactic operations. It is clear to a person skilled in the art that a frame enclosing the patient's head is a hindrance to the surgeon, since it is not all positions on the head are accessible or freely accessible and certain operative Access is not possible.

An attempt has therefore been made to develop frameless navigation techniques which allow the surgeon more freedom of action but which have the same accuracy in imaging. These methods often use implants or bone screws as "salient features" (Maciungs, RJ, LR Galloway, Jr., L. Latimer, C. Cobb; E. Zacharias, A. Moore, VR Madava. An independent application accuracy evaluation of stereotactic frame systems. Stereotact. Func. Neurosurgery 58 ( 1992 ), 103-107; Maciungs, RJ, LR Galloway, JrJ. M. Fitzpatrick, VR Madava, CA Edwards, GS Allen. A universal system for interactive image-directed neurosurgery. Stereotact.Func.Neurosurgery 58 ( 1992 ), 108-113; Burtscher, BRJ, MA Rieger, M. Giacomuzzi, A. Obwegeser, A. Daessel, C. Walch, W. Jaschke.Application of the Vogele-Bale-Hohner ( VBH) head holder in computer assisted neurosurgery. In :: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.): CARS '99: Computer Assisted Radiology and Surgery. Proceedings of the 13 ^th international Congress and Exhibition, Paris, June 23-26 , 1999. Elsevier, Amsterdam, New York, Tokyo, ( 1999 ), p 686-690) and non-invasive markers, di e are glued to the surface of the skin (Haller, JW, K. Smith, T. Ryken, J. Caplan, MW Vannier. Validation of an image-guided surgical navigation system. In: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.): CARS '99: Computer Assisted Radiology and Surgery. Proceedings of the 13 ^th international Congress and Exhibition, Paris, June 23-26 , 1999 . Elsevier, Amsterdam, New York, Tokyo, ( 1999 ), p 711-714; Glossop, N., H. Richard, G. Dix, Y. Behairy. Registration methods for percutaneous image guided spine surgery. In: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.): CARS '99: Computer Assisted Radiology and Surgery. Proceedings of the 13 ^th international Congress and Exhibition, Paris, June 23-26 , 1999 . Elsevier, Amsterdam, New York, Tokyo, ( 1999 ), p 746-750). The skin markers could be recognized in the different radiological image sets and merged using overlay techniques (matching). The markers are found on the image data record with a click of the mouse and can be accessed in the operating room. However, the use of artificial referencing markers has the disadvantage that data sets can only be overlaid if no changes have been made to the markers between the exposures. Due to the "displaceability" of the skin, an exact superimposition with this type of marking was only possible to a limited extent (Gutrie, BL, and JR Adler. Computer assisted preoperative planning, interactive surgery and frameless stereotaxy. Clin. Neurosurg. 38 ( 1992 ), 112 -131; Laborde, G., J. Gilsbach, A. Harders, L. Klimek, R. Mösges, W. Krybus. Computer-assisted localizer for planning of surgery and intraoperative orientation. Acta Neurochir. Suppl. 119 ( 1992 ), 166-170; Takizawa, Isocentric stereotactic three-dimensional digitizer for neurosurgery. Stereotact. Funct. Neurosurg. 60 ( 1993 ), 175-193; Sandemann, DR, N. Patel, C. Chandler, RJ Nelson, HB Coakham, HB Griffith Advances in image directed neurosurgery: preliminary experience with the ISG viewing Wand compared with the Leksell G frame. Br. J. Neurosurg. 8 ( 1994 ), 529-544). To date, it cannot be assumed that the skin position during the image acquisition in CT or MRI corresponds to the skin position on the operating table (Haßfeld, S. Computer-aided planning and intraoperative instrument navigation in oral, maxillofacial and facial surgery - an experimental and clinical study Quintessenz, Berlin, 2000). Increasing computer performance resulted in increased spatial resolution, which allowed the use of "natural", ie anatomical, landmarks (Arun, KS Least-square fitting of two 3-D point sets. IEEE Trans. On pattern analysis and machine intelligence 9 ( 1987 ), 698 -700; Boesecke, R., T. Bruckner, G. Ende. Landmark based correlation of medical images. Phys. Med. Biol. 35 ( 1990 ), 121-126; Rohr, K. On 3-D differential operators for detecting point landmarks, Image and Vision Computing 15 ( 1997 ), 219-233). Flat landmarks, e.g. B. the front part of the forehead or the surface of the brain with certain curvature features were also tested as suitable localization features with increasing computer power (Straster, KC Anatomical landmark image registration: validation and comparison. In: CVRMed-MRCAS '97, Springer ( 1997 ), 161-170 ; Frantz, S. Multi-step procedure for the localization of 2-D and 3-D point landmarks and automatic ROI size selection. In: Proc. ECCV 9 , Vol. I, Springer ( 1998 ), 687-703; Frontz, S. Reducing false detections in extracting 3-D anatomical point landmarks. In: Proc. 3 ^rd Workshop Image Processing for Medicine. Springer ( 1999 ), 54-59; Hartkens, T. Performance of 3-D differential operators for the detection of anatomical point landmarks in MR and CT images. In: Proc. SPIE '99 Internat. Symp. Medical Imaging: Image Processing. in press). Even in high-resolution CT, the display of very thin, lamellar bone structures (e.g. the medial orbital wall) is problematic, which as a result cannot be exactly represented in the three-dimensionally reconstructed image data set. Anatomical landmarks for the registration of the 3-dimensional position therefore turned out to be too imprecise. Deviations of up to 5 mm have been observed (Horstmann, GA and HF Reinhardt. Ranging accuracy test of the sonic microstereometric system. Neurosurgery 34 ( 1994 ), 754-755; McDermott, MW and PH Guthin. Image guided surgery for skull base neoplasmas using the ISG viewing wall. NEUROSURG: Clin. N. Am. 7 ( 1996 ), 285.295; Kondziolka, D. and LD Lunsford. Intraoperative navigation during resection of brain metastases. Neurosurg. Clin. N. Am. 7 ( 1996 ), 267 -277).

In all of the above-mentioned methods, the surgeon must manually or semi-automatically extract areas relevant to the operation from the image data sets or superimpose them on the computer screen. Current trends are therefore aimed at automated matching processes. The "tomogram transformation" takes place on the basis of algorithms based on gray values, in which homogeneous regions of different image data sets are superimposed (Eldeib, A, AA Farag, T. Moriarty, ibid .; Jannin, P., Ch. Grova, D. Schwartz , Ch. Barillot, B. Gibaud, ibid .; Rohlfing, T., J. Beier, R. Graf, M. Wolf, P. Wust, R. Felix. Automated integration of CT, MRI and PET for planning and dose distribution computation in raiation therapy. In: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.) CARS '99, Computer Assisted Radiology and Surgery. Elsevier, Amsterdam, New York, Tokyo ( 1999 ), p. 279-283). The arithmetic operations that used to last several hours (Collignon, A., D. Vandenmeulen, P. Suetens, G. Marchal.

3-D multi-modality medical image registration using feature space clustering. In: Ayache, N. (ed.) Computer Vision, Virtual Reality and Robotics in Medicine. Proceedings First Internat. Conference, CVRMed '95. Nice, France April 3-6, 1995. Springer, Berlin, Heidelberg, New York, London, Tokyo ( 1995 ), p. 195-204) can be processed in minutes with increasing computer speed.

Based on the frameless navigation and localization techniques (Computer Assisted Surgery), the surgeon is able to determine the position of the instruments he is guiding (pointer, scalpel, endoscope, etc.) on the three-dimensionally reconstructed image data set of the respective patient in "real time" on the To display computer screen. It is also possible to define pathological or anatomical structures in the surgical site. Here too, markers are used to correlate spatial patient anatomy and three-dimensionally reconstructed anatomy of the image data set. Position-sensing articulated arms were initially developed for navigation (Watanabe, ibid. 1987; Legett, WB, MM Greenberg, WE Gannon, D. Dekel, CJ Gabe. Surgical Technology. The Viewing Wand: A new system for three-dimensional coputed tomography-correlated intraoperative localization. Curr. Surg. 48 ( 1991 ); Adams, ibid. 1991; Zamorano, L., AM Kadi, A. Dong. Computer assisted neurosurgery: simulation and automation. Stereotact. Funct. Neurosurg. 59 ( 1992 ), 115- 122; Zinreich, SJ, SA Tebo, DM Long, H. Brem, DE Mattox, ME Loury, CA von der Kolk, WM Koch, DW Kennedy, RN Bryan.Frameless stereotactic integration of CT imaging data: acuracy and initial applications. Radiology 188: 735-742 ( 1993 )). The "Neuronavigator" introduced by Watanabe in 1987 showed an accuracy of ⇐ 2.5 mm with the help of a position-sensing articulated arm. Further experimental systems were developed by Kosugi, Kwoh, Lavallee, Galloway, Laborde, Klimek, Koivukangas and Takizawa (Kosugi, ibid. 1988; Kwoh, YS, J. Hou, E. Jonckheere, S. Hayati. A robot with improved absolute positioning accuracy for CT guided stereotactic surgery. Trans. Biomed. Eng. 35 ( 1988 ), 153-161; Lavallée, S., P. Clinquin. IGOR: Image Guided Operating Robot. 5 ^th Int. Conf Advanced Robotics, Pisa, Italy 1991 ; Galloway RL, RJ Macinuas, CA Edwards. Interactive image guided neurosurgery. IEEE Trans. Biomed. Eng. 39 ( 1992 ), 1226-1231; Laborde, ibid. 1992; Klimek, ibid. 1992; Koivukangas, D., Y. Louhisalmi , J. Alakuijala, J. Oikarinen, Ultrasound controlled neuronavigator guided brain surgery, J. Neurosurg. 79 ( 1992 ), 36-42; Takizawa, ibid. 1993). The first commercial system was the viewing wall system from ISG, which was increasingly used in neurosurgery from 1993 (Hassfeld, ibid. 2000). The accuracy is given in the range of 2-4 mm (Mösges, ibid. 1993; Sandemann, ibid. 1994; Peters, TM, CJ Munger, AM Takahashi, AC Evans, B. Davey, A. Olivier. Integration of stereoscopic DAS and 3D MRI for image guided neurosurgery.

Comput. Med. Imaging Graph. 18: 289-299 ( 1994 ); Golfinos, JG, BJ Fitzpatrick, LR Smith, RF Spitzler. Clinical use of a frameless stereotactic arm: results of 325 cases. J. Neurosurg. 1995 , 83: 197-205; Nabavi, A., G. Manthei, U. Blömer, L. Kumpf, H. Klinge, HM Mehdorn. Neuronavigation - Computer-assisted surgery in neurosurgery. Radiologie 35, 573-577 ( 1995 ); Otsubo, H., PA Hwang, A. Hunjan, D. Armstrong, S. Holowka, JM Drake, HJ Hoffmann. Use of frameless stereotaxy with location of electroencephalographic electrodes of three-dimensional computed tomographic images in epilepsy surgery. J. Clin. Neurophysiol. 12 ( 1995 ) 363-371; Pollack, IF, AL Albright, PD Adelson, CR Fitz. The role of frameless stereotactic techniques in the treatment of mepiatric CNS lesions. Pediatr. Neurol. 1995 , 13: 209-216; Carney, AS, N. Patel, DL Baldwin, HB Coakham, DR Sandeman. Intraoperative image guidance in otolaryngology - The use of the ISG viewing wand. J. Laryngol. Otol. 110: 322-327 ( 1996 ); Kondziolka, ibid. 1996; McDermott, ibid. 1996; Oliver, A., M. Alonso-Vanegas, R. Corneau, TM Peters. Image guided surgery of epilepsy. Neurosurg. Clin. N. Am. 7: 229-243 ( 1996 ). The "Padyc" presented in 1996 by Troccaz and Delnondedieu (Troccaz, JY Delnondedieu. Semi-active guiding systems in surgery. A two-dof prototype of the passive arm with dynamic constrains (PADyC). Mechanotronics 6 ( 1996 ), 399-431) , a semi-active robot with a mechanical arm and the possibility of restricting movement to a specific target volume, made it possible to cut out high-risk regions intraoperatively (Hassfeld, ibid. 2000).

Automated-navigated computer-assisted articulated arms and robots, i.e. independently operating systems, are currently in the experimental phase (Taylor, RH An image directed robotic system for precise orthopedic surgery. IEEEE Trans. Robotics Automation 10 ( 1994 ), 261-275; Lueth, TC , A. Hein, J. Albrecht, M. Demirtas, S. Zachow, E. Heissler, H. Klein, H. Menneking, G. Hommel, J. Bier. A surgical robot system for maxillofacial surgery. IEEE Int. Conf. On industrial electronics, control and instrumentation (IECON) Aachen, Aug 31-Sept 4, 1998, 2470-2475) and clinical trials (Hein, A., TC Lueth, J. Bier, G. Hommel. A robotic retractor hook holder. In: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.) CARS '99, Computer assisted radiology and surgery. Elsevier, Amsterdam, New York, Tokyo ( 1999 ), p. 823-827 ).

In summary, it should be noted that systems controlled with the aid of a measuring arm always remain limited in use due to the forced operation. Constricted by design the often reduced space available at the operating table.  

In contrast to the mechanically coupled navigation systems, armless, free systems have also recently been developed which operate on the principle of satellite navigation, e.g. B. based on ultrasound, magnetic field or optically (Nitsche, N., M. Hilbert, G. Strasser, HP Tümmler, W. Arnold. Use of a non-contact computer-based orientation system for sinus surgery. Technical basics of sonar stereometry. Otorhinolaryngol. Nova 3 ( 1992 ), 173-179; Barnett, GH, DW Kormos, CP Steiner, J. Weisenberger. Intraoperative localization using an armless, frameless stereotactic Wand. Technical note. J. Neurosurg. 78 ( 1993 ), 510-514; Reinhardt, ibid 1993; Buchholz, RD, KR Smith, C. Baumann, L. McDumont, D. Schulz. Intraoperative localization with an optical digitizer. Stereotact. Funct. Neurosurg. 63 ( 1994 ), 100).

Ultrasound-based instrument navigation systems were first introduced in the form of a stereotactic surgical microscope from Roberts (Roberts, ibid. 1986). The localization was based primarily on distance measurements. Based on the surgical instruments that usually carry the ultrasound transmitter, the impulse goes to receivers that are distributed in the operating room. The intraoperative accuracy is given as 2-5 mm (Reinhardt, HF, GA Horstmann, O. Gratzl. Microsurgical removal of deep vascular malformations with the aid of sonar stereometry. Ultrasound Med. 12 ( 1991 ), 80-84; Barnett, ibid. 1993 ; Horstmann, ibid. 1994; Kalfas, IH, DW Kormos, MA Murphy, RL McKenzie, GH Barnett, GR Bell, CP Steiner, MB Trimble, RT Weisenberger. Application of frameless stereotaxy to pedicle screw fixation of the spine. J. Neurosurg 83 ( 1995 ), 641-647; Barnett, 1996)). Due to the system there are deviations in accuracy due to temperature or air movements, which is why this form of navigation has so far hardly been used (Hassfeld, ibid. 2000).

With magnetic field-based localization, navigation is based on changes in the field strength of electromagnets attached to instruments. Such systems have been developed by Kato (Kato, A., T. Yoshimine, T. Jayakawa, Y. Tomita, T. Ikeda, M. Mitomo, K. Harada, H. Mogami. A frameless, armless navigation system for computer assisted neurosurgery. Technical note. J. Neurosurg. 74 ( 1991 ), 845-849), Manwaring (Manwaring, KH, ML Manwaring, SD Moss. Magnetic field guided endoscopic dissection through a burr hole may avoid more invasive craniotomies. Acta Neurochir. Suppl 61 ( 1994 ), 34-39) and Wagner (Wagner, AO Ploder, G. Enslidis, M. Truppe, R. Ewers. Virtual image guided navigation in tumor surgery - technical innovation. J. Craniomaxillofacial Surg. 23 ( 1995 ), 271- 273; Wagner, AO Ploder, G. Enslidis, M. Truppe, R. Ewers. Image-guided surgery. Int. J. Oral; axillofacial Surg. 25 ( 1996 ), 147-151). As with other navigation systems, the clinical accuracy is given in the range of 2-4 mm. Deviations from the accuracy are particularly difficult to rule out due to electromagnetic interference fields - especially in the OR due to large metal masses.

Optical navigation systems have prevailed due to the technical precision and the lack of influence by the ambient conditions in the operating room in the form of infrared light-based navigation technology. The navigation instruments contain infrared light emitting diodes. The receiver cameras are installed either individually or as bar receivers in the operating room (Heilbrunn, MP, P. McDonald, C. Wiker, S. Koehler, W. Peters. Stereotactic localization and guidance using a machine vision technique. Stereotact. Funct. Neurosurg. 58 ( 1992 ), 94-98; Reinhardt, ibid. 1993; Smith, KR, KJ Frank, RD Buchholz. The Neurostation - A highly accurate, minimally invasive solution to frameless stereotactic neurosurgery. Comput. Med. Imaging Graph. 18 ( 1994 ), 247-256; League, D. Interactive, image-guided, stereotactic neurosurgery systems. AORNJ 61 ( 1995 ), 360-370; Westermann, B., M. Trippel, H. Reinhart. Optically-navigable operating microscop for image guided surgery .Mini. Invasive Neurosurg. 38 ( 1995 ), 112-116; Nomura, T., E. Kobayashi, K. Masamung, I. Sakuma, T. Dohi, H. Iseki, K. Takakura. In: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.) CARS '99, Computer Assisted Radiology and Surgery. Elsevier, Amsterdam, New York, Tokyo ( 1999 ), 813-822). The system accuracy is given as less than 1 mm, the intraoperative accuracy on the patient with 2 to 4 mm (Germano, IM The NeuroStation system for image guided, frameless stereotaxy. Neurosurg. 37 ( 1995 ), 348-350; Buchholz, RD, DJ Greco Image guided surgical techniques for infections and trauma of the nervous system. Neurosurg. Clin. N. Am. 7 ( 1996 ), 187-200; Foley, KT, MM Smith. Image guided spine surgery. Neurosurg. Clin. N. Am 7 ( 1996 ), 171-186; Krückels, G., B. Korves, L. Klimek, R. Mösges. Endoscopic surgery of the rhinobasis with computer assisted localizer. Surg. Endosc. 10 ( 1996 ), 453-456; Macunias, RJ, MS Berger, B. Copeland, MR Mayberg, R. Selker, GS Allen. A technique for interactive image-guided neurosurgical intervention in primary brain tumors. Neurosurg. Clin. N. Am. 7 ( 1996 ), 245- 266; Nolte, LP, H. Visarius, E. Arm, F. Langlotz, O. Schwarzenbach, L. Zamorano. Computer-aided fixation of spinal implants. J. Image Guided Surg. 1 ( 1995 ), 88-93; Reinhar dt, HF Neuronavigation: A ten-year review. In: Taylor, RH, Lavalee, S., Burdea, BC, Mösges, R. (eds.) Computer-integrated Surgery. MIT Press, Cambridge (MA), London ( 1996 ), 663-671). When using an optical navigation system and referencing via the individual bite splint disclosed in this document, an intraoperative accuracy of 0.9-1.2 mm (Schramm, A., N.-C. Gellrich, H. Buitrago-Téllez, H. Frommhold, R. Schmelzeisen, Computer assisted treatment of maxillofacial tumors, J. Craniomaxillofac, Surg. 26 ( 1998 ) ;; Schramm, A., N.-C. Gellrich, R. Schön, R. Schimming, R. Schmelzeisen. Advantages of computer assisted surgery in the treatment of craniomaxillofacial tumors. In: Lemke, H., Inamura, K., Vannier, MW, Farmann, AG (eds.) CARS '99, Computer Assisted Radiology and Surgery. Elsevier, Amsterdam, New York , Tokyo ( 1999 ), 903-907;). A number of commercial navigation systems are offered: e.g. B. the Flash Point 3D Localizr system from Pixsys (Boulder, CO, USA), the Optotrac system from Northern Digital (Waterloo, Ont., Canada) and the SPOCS system from Aesculap ( Tuttlingen, FRG), as well as the STN system from Zeiss (Oberkochem, FRG) and Image guided Technologies (Florida, USA) used by us.

The accuracy of frameless navigation systems is mostly given in the range of 3-5 mm (Barnett, ibid. 1993; Mösges, ibid. 1993; Reinhardt, ibid. 1993; Sandemann, ibid. 1994; Zamorano, L., Z. Jliang, AM Kadi Computer-assisted neurosurgery system: Wayne State University hardware and software configuration. Comput. Med. Imaging Graph. 18 ( 1994 ), 257-271). From a surgical point of view, an area of <2 mm is aimed for. The precision of such systems is considerably greater than in soft tissue for reasons of mobility in the bone and in the area near the bone (Sandemann, ibid. 1994).

The documents US 5,588,430 and US 5,954,647 describe a method for the Reproducible coordinate setting for medical procedures on a bite plate based, which carries fiducial markers. After taking the impression, the bite plate is specially made for the The patient is made in several steps in the laboratory and therefore fits exactly on the teeth of the Patient and is repeated when performing various imaging procedures or worn during the surgical procedure. The determination of anatomical or other peculiarities is in a known position relative to that on the bite Plate attached fiducial markers. The preparation of these in these writings described bite plate is time and persolina intensive and requires access to one dental laboratory. In the event of an impression error, the plate cannot be used and it takes a long time to make a replacement. An unsolved problem poses in these Written method described the plate fixation in patients with edentulous jaws because no bite plate can be made for them.

From the foregoing, it is an object of the invention to provide a frameless bracket for Referencing markers (navigation rail) or fiducials for creating image data for a database using magnetic resonance imaging, computed tomography or other imaging To create techniques that are used for reproducible, highly accurate position detection  the position of a patient and the assignment of coordinates during surgical interventions without that by the required reproducible attachment of the marking device preoperatively Disadvantages for the patient arise up to the operation.

Furthermore, it is an object of the invention to provide a referencing system by which the field of operation is not restricted or the activity of the surgeon is not hindered becomes.

Ultimately, it is an object of the invention to provide a navigation rail that is based on different jaw ratios is adaptable.

The assembled navigation rail presented here solves these tasks and leads to Solution to other problems to be described.

The object of the invention is achieved with regard to the assembled Navigation rail according to the definition of claim 1; regarding use in a medical procedure according to the features of claim X.

The subclaims provide at least practical configurations and Developments of the respective subject of the invention or the use.

The basic idea according to the invention with regard to the referencing system for Execution and support of surgical interventions in the head and neck area consists in the training of known solutions in such a way that one of the Known impression tray a navigation rail is developed, which on the Provide the outside with at least four basic elements for attaching fiducials which are arranged in a defined XYZ axis.

The invention is intended to be explained below with the aid of exemplary embodiments and with the aid be explained in more detail by figures.

Here show:

Fig. 1 shows the assembled form of an upper jaw navigation rail with attached fiducials.

Fig. 2 execution of the navigation rail as an oral atrial rail

Navigation systems are required for preoperative planning and intraoperative control Image data of the patient's anatomical structures that are as accurate as possible. This image data are either by computed tomography, magnetic resonance imaging and / or others imaging techniques provided.  

CT imaging is advantageous when it comes to imaging is about bony structures. For the representation of soft tissues, e.g. B. the brain, magnetic resonance imaging is preferred. For admission and for subsequent So-called markers are attached to the position of the patient's head. The markers have a substance which, depending on the tomography method used, for a sufficient contrast and thus recognizability of the markers.

After data transfer via a local network or appropriate storage media the diditalized recordings are processed automatically, with the aim of this Refurbishment or image editing consists of a 3D representation of the operation to be performed To reach the area as authentically as possible in order to allow the surgeon to perform the procedure before to be able to plan the operation and make it minimally invasive. about Segmentation steps become possible by using mathematical methods created to work out certain anatomical structures from the sum data sets. For navigation it is then necessary to establish a connection between the received virtual image, which can be created from the digitized data, and the real one To manufacture an object in the operating room.

For this, clear positions are required, which can be found both in the real and in the Find the virtual system in the correct position. To determine such positions, additional markers are used, which serve as reference points. The markers are in the same environment as those used for MR or CT Recordings were used.

For the reasons mentioned above, intraoperative navigation procedures are required Reference points or markers or fiducials. These markers are made of materials that are in nuclear spin or computer tomography and / or other imaging processes have it proven. Taking into account the required precision, but also with Taking skin shift into account, marker systems were known to be caused by Screw connection to the skull bone to be fixed. Alternatives are the use of Dental splints, which the patient during the examination with tomography and also in Operating room must keep firmly in the mouth. Such methods are high financial and time expenditure connected and in their application for the patient extremely uncomfortable. The screwing in of markers can be done with this associated invasive action can usually only be done by a doctor what the costs further increased.  

Therefore, according to the basic idea of the invention, a special one Marking device for creating image data for a database using Tomography on the one hand and on the other hand for the position detection of the position of a subject and coordinate assignment during surgery. The new Navigation rails are pre-configured for quick and inexpensive Designed for patient use.

The indication for the use of the new navigation rail depends on various factors. For fully edentulous or slightly incomplete jaw conditions, the upper jaw splint is recommended as shown in Fig. 1. The navigation rail is based on commercially available casting spoons in various sizes, which allow adaptation to the shape of the patient's dental arch: the narrow shape for the child's upper jaw and the larger, prefabricated spoons for the increasingly wide adult upper jaw. The basic shape of the navigation rail is based on the upper jaw impression tray and should primarily be made from plastic materials known to those skilled in the art that are not X-ray-opaque, so that artifacts are not formed in radiological representations. As is known to the person skilled in the art, various techniques are available for the production of these plastic impression trays, preferably the injection molding process. The spoon base ( 100 ) and the spoon handle ( 101 ) should be made of the same material. The spoon should contain perforation holes ( 102 ) for better adhesion. A plurality of, at least three, but not more than ten, preferably four to six, detent buttons ( 103 ) for attaching the tomography markers ( 104 ) are not necessarily symmetrically attached to the outside of the impression tray.

The actual marking substance is made up of an essentially cylindrical housing, which is easy to handle. The housing base preferably has one concave shape or a recess, with an essentially at the bottom of the housing central locking receptacle or a locking counterpart is arranged based on the locking button. By the patent US 5 394 457, which is hereby incorporated in its entirety as a reference such markers are known.

The locking button on the one hand and the locking receptacle or the locking counterpart on the other enable easy attachment and replacement of the cylindrical housing with the Labeling substance.

The marking substance for the imaging process itself is a liquid, a gel or a solid, which (s / r) is in a spherical or closed cylinder vessel  is located, the outer diameter of the ball or the cylinder substantially the Inner diameter of the cylindrical housing with snap-in receptacle or snap-in counterpart equivalent. The substance used is specific to imaging techniques and can can be exchanged using the locking buttons. The substance can preferably be chosen such that it is clearly visible in the nuclear spin in both the T1 and T2 weighted images. simultaneously the marking is preferably selected so that it over the difference in contrast between the Ball and the housing can also be clearly seen in computer tomography. In this manner Even if you choose the wrong marker, you can still do it relatively easily Any marker selected by the user is recognized on the CT or X-ray images become. This measure is used in the event of an incorrectly selected marking aid no need to measure the patient again and especially with CT Examination to prevent additional radiation exposure.

The alignment of the locking buttons ( 103 ) is chosen along the three dimensions - in the sagital, frontal or horizontal plane - preferably so that a maximum difference between the respective vectors in the respective spatial planes arises.

After attaching the required MRI or CT / X-Ray markers ( 104 ) to the locking buttons ( 103 ), the spoon can be fitted in the patient's mouth. Removable dentures with the exception of full dentures should be removed beforehand. After selecting the suitable tray size, the controlled mixing of the silicone impression material and the impression take place.

The manufacture of splints is preferred in the single-phase impression technique carried out.

In principle, all impression materials familiar to a person skilled in the art can be used, especially putty materials (highly filled silicones) or classic silicones. In a preferred embodiment, the plastic impression tray with the help of a Polyvinyl adhesive known to those skilled in the art, for example one from ESPE (Seefeld, FRG) prepared for the inclusion of the A-silicone. According to one of the manufacturers of the Adhesive period, usually 5 to 15 minutes, the transparent, highly filled addition-crosslinked silicone Memosil C. D. in the form of the Mixing Tips System of Heraeus-Kulzer GmbH & Co. KG, Dormagen (BRG) for taking the impression on the Spoon applied. After positioning the navigation bar in the patient's mouth the patient closes his mouth. The processing time is known to the person skilled in the art and is 2-3 minutes depending on the product and ambient temperature. As the expert knows, is in the A correction of the position of the splint is possible in the initial phase of the polymerization. During the  Setting phase should avoid gross movements. As the expert knows, that is The setting phase is completed after about 5 minutes. Then the Navigation splints are taken out of the patient's mouth and, according to the Expert disinfection of the impression in the disinfection bath can, if necessary excess impression material in a manner known to the person skilled in the art, for example with the Scalpel. After repeated cleaning of the impression, the Reintegration of the navigation impression into the patient's mouth. The "Exact fit" of the reduced impression is determined by the examiner and also the Patients assessed.

Another type of impression is single-phase, two-phase impression. This method, which is also known as a double-mixing technique (Scholl, R. The double-mix impression with "Dimension Penta H" ZMK 10 ( 1999 ), Suppl .: pp. 5-7), can be used, for example, in a manner known to those skilled in the art with the product combination Dimension Penta H Quick , Dimension Garant L Quick and the polyvinyl siloxane adhesive from ESPE (Seefeld, Germany).

With the help of the new, assembled navigation rail, the patient can move to or between the tomography images are freed from the assembled navigation rail and move freely. For further recordings and for later operative Treatment, the assembled navigation rail can be used again in the exact position and there can be special measuring aids in the operating room using the on the rail locking buttons can be attached.

In patients with increased gag reflex or pathological changes in the palate, such as slightly bleeding hemangiomas, the special embodiment of the navigation rail shown in FIG. 2 in the form of an oral atrial rail can be used.

The basic shape of the oral atrial splint, also known as a prefabricated navigation splint for the edentulous jaw, is a plastic atrial shield ( 200 ) with perforation holes ( 202 ), on the outside of which a handle ( 201 ) and, not necessarily symmetrically, a plurality, at least three and no more than ten, preferably four to six, snap buttons ( 203 ) are attached for the attachment of the tomography markers ( 204 ). The alignment of the locking buttons ( 203 ) is chosen along the three dimensions - in the sagital, frontal or horizontal plane - preferably so that a maximum difference between the respective vectors in the respective spatial planes arises. The assembled navigation rail for the edentulous jaw should primarily be made from plastic materials known to the person skilled in the art, which are not X-ray-opaque, so that artifacts are not formed in radiological representations. Different techniques known to those skilled in the art and dependent on the plastic used are suitable for producing this type of navigation rail, preferably the injection molding process. During the taking of the impression, the prosthesis should remain in the patient's mouth to secure the bite position. The handling of the oral atrial splint is similar to that of the navigation splint for the edentulous jaw.

In general, the use of the oral atrial splint is recommended for partial or full prosthetics restored jaw. Before making splints, make sure that intubation is possible and makes sense from an operational point of view.

Patients with dysmorphisms of the midface or tooth-bearing parts of the jaw can can also be supplied with assembled navigation rails. A spoon adjustment on the plaster model, which is usually made for operation planning, can be used here Check the spoon size or extension.

All in all, the above invention succeeds in specifying a referencing system which is made easy by using a pre-assembled navigation rail an exact overlay of different ones obtained by CT and MR Data records of a patient. On the basis of common dental The navigation rail can take impression materials at any time at short notice and independently of the laboratory are manufactured. The production remains due to the simple rail production navigable three-dimensional image data sets not only on secondary or long-term predictable interventions limited, but can also immediately post-traumatic or on unconscious or intubated patients. This means that the operator Already with the primary care of the patient the possibilities of minimally invasive designed computer-assisted or assisted surgery.

Through the use of the assembled navigation rails disclosed here in their Different embodiments can be the temporal, personnel as well as material Use in preparation for the acquisition of 3-D data sets for computer-aided or assisted surgery significantly reduced compared to conventional methods become.

Claims (13)

1. Carrier of marking devices or fiducials for creating image data for a database by means of magnetic resonance imaging, computed tomography or another imaging digital method as well as for position detection of the position of a subject and coordination assignment during surgical interventions with the support of a navigation device, comprising a carrier which can be attached to the subject's jaw and a contrast marking substance located in at least three containers, characterized in that
the carrier is designed as a ready-made navigation rail,
the containers containing the contrast marking substance are exchangeably fastened in a plurality of snap buttons on the outside of the carrier,
the carrier can be repeatedly placed on the patient in the exact position. 2. Assembled navigation rail according to claim 1, characterized in that
the carrier is designed as a maxillary impression tray
the containers containing the contrast marking substance are exchangeably attached to the outside of the carrier in three to ten, preferably less than ten and particularly preferably four to six locking buttons,
the carrier can be repeatedly placed on the patient in the exact position. 3. Assembled navigation rail according to claim 2, characterized in that
the carrier is made of radiopaque material
the containers containing the contrast marking substance in four to six locking buttons on the outside of the carrier along the three dimensions - in the sagital, frontal or horizontal plane - preferably in such a way that a maximum difference between the respective vectors arises in the respective spatial planes be attached
the carrier can be repeatedly placed on the patient in the exact position. 4. Assembled navigation rail according to claim 1, characterized in that
the carrier is designed as an oral atrial splint
the containers containing the contrast marking substance are exchangeably attached to the outside of the carrier in three to ten, preferably less than ten and particularly preferably four to six locking buttons,
the carrier can be repeatedly placed on the patient in the exact position. 5. Assembled navigation rail according to claim 4, characterized in that
the carrier is made of radiopaque material
the containers containing the contrast marking substance in four to six locking buttons on the outside of the carrier along the three dimensions - in the sagital, frontal or horizontal plane - preferably in such a way that a maximum difference between the respective vectors in the respective spatial planes arises be attached
the carrier can be repeatedly placed on the patient in the exact position. 6. Assembled navigation rail according to claim 3 or 5, characterized characterized in that the attachment includes making a dental impression around the Navigation rail in register with the natural, prosthetically replaced teeth or to bring the patient's edentulous jaw sections and that Reinstalled by the imprint contained in the navigation rail Teeth, the prosthetic restoration or the edentulous jaw sections of the Patients the navigation rail exactly in the previous position. 7. A medical method that, not necessarily in sequence, includes the following steps:
attach a mechanically free reference rail with a plurality of fiducials to the patient in register with a body part of the patient;
position a patient for a first medical procedure;
perform a first medical procedure and use the fiducials to obtain precise positioning information relative to at least part of the patient;
remove the referencing marker from the patient after the first medical procedure;
at a later time after removing the referencing marker, put the referencing marker back in register with a part of the patient's body, thereby obtaining an identical positioning as before;
after the reference marker has been reattached, the fiducials obtain an exact positioning relative to at least part of the patient; and
after reinstallation, performing a second or further medical procedure on the patient. 8. A medical method according to claim 7, characterized in that the Attaching and reattaching the navigation bar is non-invasive. 9. A medical method according to claim 8, characterized in that the Referencing marker is a ready-made navigation rail that has a plurality of fiducials on the outside, and where the attachment is made of a tooth impression encloses the navigation rail in register with the Bring the patient's teeth and being reattached by the in the Imprint of the patient's teeth included on the navigation bar Brings the navigation rail exactly into the previous position. 10. A medical method according to claim 9, characterized in that the Referencing marker a ready-made navigation rail according to claim 3 or 5, and wherein the attachment is the making of a dental impression includes around the navigation rail in register with the natural, the prosthetic to replace replaced teeth or the edentulous jaw sections of the patient and the reattachment by the imprint contained in the navigation rail the teeth, the prosthetic restoration or the edentulous sections of the jaw Patients the navigation rail exactly in the previous position. 11. A medical method according to claim 7 to 10, characterized in that that the first medical procedure is an imaging procedure, at least gives a picture of part of the patient. 12. A medical method according to claim 7 to 11, characterized in that that the second medical procedure is a procedure whereby the first Procedures diagnosed or treated precisely localized problem further becomes. 13. A medical method according to claim 7 to 12, characterized in that that the data sets obtained in the imaging processes for the generation of 3-D High quality records can be overlaid precisely, reducing detection of differences in location, extent or other qualitative and quantitative features of anatomical or pathological nature.